Safety trocar

ABSTRACT

A safety trocar is provided which includes a spring-loaded shield that shields the cutting tip of the obturator after the obturator penetrates tissue. The distal end of the shield is hemispheric in profile and contains a slot which conforms to the geometry of the cutting tip. The rounded distal end enables the shield to spring forward to shield the cutting tip as soon as the tip perforates the tissue. A valve is located at the proximal end of the trocar tube to seal the end of the tube. The valve is oriented at an acute angle with respect to the longitudinal axis of the trocar tube. The valve is controllable by an external lever which will hold the valve open or permit it to spring shut. An incremental advancement mechanism cooperates with the obturator to permit only incremental advance of the obturator. Instead of using a discrete shield component the shielding function may be provided by spring-loading the trocar tube itself to spring forward and shield the obturator tip after the tip penetrates tissue.

This is a continuation of application Ser. No. 371,953, filed Jun. 27,1989, now U.S. Pat. No. 5,066,288.

This invention relates to trocars used to puncture tissue for theperformance of laparoscopic or arthroscopic surgery and, in particular,to such trocars which employ a safety device to shield the obturatorpoint immediately after the point has perforated tissue.

A trocar generally comprises two major components, a trocar tube and anobturator. The trocar tube is inserted through the skin to access a bodycavity through the tube in which laparoscopic or arthroscopic surgery isto be performed. In order to penetrate the skin, the distal end of thetrocar tube is placed against the skin and an obturator is insertedthrough the tube. By pressing against the proximal end of the obturatorthe point of the obturator is forced through the skin until it entersthe body cavity. At this time the trocar tube is inserted through theperforation made by the obturator and the obturator is withdrawn,leaving the trocar tube as an accessway to the body cavity.

It has been found that often a great deal of force is required to causethe obturator point to penetrate the skin and underlying tissue. Whenthe point finally breaks through this tissue, resistance to penetrationis suddenly removed, and the obturator point can suddenly penetrate toreach internal organs of the body, which may cause lacerations and otherinjury to the internal organs. To avert this danger to the patient,trocars have been developed which carry a spring-loaded tubular shieldwithin the trocar tube and surrounding the obturator. The distal end ofthe shield will press against the skin as the obturator point penetratesthe body until the obturator has formed a perforation with a diametersufficient to allow the shield to pass through. At that time theresistance of the tissue to the spring-loaded shield is removed, and theshield will spring forward to extend into the body cavity, surroundingthe point of the obturator. The shield thus protects the internal bodyorgans from inadvertent contact with the point of the obturator. Atrocar including such a safety shield is described in U.S. Pat. No.4,535,773, for example.

The tubular shield in such a trocar will, however, require the incisionformed by the obturator to extend to a considerable diameter before theresistance of the tissue pressure has been sufficiently decreased toallow the safety shield to spring forward. It is only when the incisionattains the diameter of the shield that the shield is fully able tospring into the body cavity. When the obturator employs a long, taperedcutting tip, this tip must extend a significant distance into the bodybefore the incision is sufficiently enlarged to release the safetyshield. It would therefore be desirable to provide a safety shield whichwill spring forward to shield the obturator tip as soon as possibleafter entry is gained to the body cavity.

In accordance with the principles of the present invention, a safetyshield for a trocar obturator is provided which exhibits a rounded,bullet-shaped distal end. A slot is formed in this distal end whichcorresponds to the geometry of the obturator tip, through which the tipextends during perforation of the skin. With this distal end conformingto the geometry of the tip, a smooth transition is provided from the tipto the distal end of the shield, enabling the shield to closely followthe obturator tip through the tissue. The rounded distal end will pressagainst the skin and tissue in close proximity to the periphery of theincision as it is formed, and will aid in the enlargement of theincision to enable the shield to spring forward as soon as entry isgained into the body cavity.

It is desirable for the obturator to slide smoothly within the trocartube during both insertion and retraction of the obturator. Opposingthis desire is the need to form the obturator to be nearly the samediameter as the tube, so that the perforation will be the size of thetube. Thus, tolerances are generally tight between the outside diameterof the obturator and the inside diameter of the trocar tube. Furthercomplication is provided by the valve at the proximal end of the trocartube, which is needed to seal the proximal end during removal of theobturator when the trocar tube and body cavity are insufflated withgases. The valve, which generally takes the form of a hinged flap ortrumpet valve, is spring-loaded to bear against the obturator, therebyassuring that the valve will close automatically upon withdrawal of theobturator of the tube. As the valve bears against the obturator it willfrictionally disrupt the entry and withdrawal of the obturator, and attimes can even jam and lock the obturator within the trocar tube.

In accordance with a further aspect of the present invention, the valvewithin the proximal end of the trocar tube is oriented at an acute anglewith respect to the trocar tube when the valve is closed. Ease of entryof the obturator or any endoscopic instrument is afforded when theshielded tip of the obturator or instrument presses against theangularly disposed valve, and the angular orientation minimizes jammingof the obturator or instrument and valve within the trocar. In apreferred embodiment the valve is manually controllable in discretepositions for insufflation, desufflation, and valve closure in concertwith the operation of a gas fitting.

Further patient safety would be provided by preventing the suddenextension of the obturator into the body cavity as the obturator tipfully penetrates the tissue. In accordance with yet another aspect ofthe present invention, means are provided which permits only incrementaladvancement of the obturator as tissue penetration proceeds. Suchincremental advancement is provided by a ratchet or screw mechanism, forinstance.

It would further be desirable to provide the safety of the trocar withthe safety shield, but in a device which reduces the componentcomplexity of the trocar and tube with the spring-loaded safety shield.In accordance with still another aspect of the present invention, thetrocar tube is spring-loaded and employed as the safety shield. Thus, asthe obturator point breaks through the tissue, the trocar tube willspring forward automatically into the body cavity, thereby providingshielding about the tip of the obturator.

In the drawings:

FIGS. 1-4 illustrate the use of the trocar tube to provide shielding ofthe obturator tip;

FIGS. 5a-8 illustrate a trocar safety shield with a bullet-shaped nose;

FIGS. 9-11b and 18 illustrate operation of a trocar with a bullet nosedshield;

FIGS. 12-12d illustrate a bullet nosed safety shield when used with atriangular-pointed obturator;

FIGS. 13-15b illustrate operation of a trocar with a bullet nosed shieldand a triangular-pointed obturator;

FIGS. 16 and 17 illustrate the penetration of tissue by a trocar with abullet nosed safety shield;

FIGS. 19-21 illustrate a trocar with an angularly disposed valve at theproximal end of the trocar tube;

FIG. 22 illustrates apparatus for permitting only incrementaladvancement of the obturator of a trocar;

FIGS. 23-26 illustrate a control on a trocar for regulating insufflationof the body; and

FIGS. 27 and 28 illustrate an obturator and shield combination whichrequires only a short extension of the obturator from the distal end ofthe shield.

A safety trocar constructed in accordance with the principles of thepresent invention is shown in FIG. 1. The trocar includes a trocar tubeor cannula 10 having an open distal end 12 and an open, flanged proximalend 14. The proximal end 14 is mounted in a trocar handle 16. A spring18 is located inside the handle and abuts the flanged end of the trocarcannula 10 and a stop 19 within the handle 16. There is an aperture 20at the proximal end of the handle 16 which is surrounded by a gasketring 22.

An obturator 24 is slideably and removeably located within the trocarcannula and is inserted into the handle and trocar cannula by way of theaperture 20. At its proximal end is an obturator handle 26, and thedistal end of the obturator is sharpened to a point 28. The safetytrocar of FIG. 1 is used to puncture a hole in soft tissue by placingthe distal end 12 of the trocar cannula 10 against the tissue, andpressing against the obturator handle 26. As pressure is exerted againstthe obturator handle, the trocar cannula 10 begins to compress thespring 18 inside the trocar handle 16 and the trocar cannula retractsinto the handle 16. This retraction of the trocar cannula exposes theobturator point 28, which punctures the tissue. FIG. 2 shows the spring18 fully compressed within the trocar handle 16 and the obturator point28 fully exposed beyond the distal end 12 of the trocar cannula. Whenthe obturator point 28 breaks through the inner surface of the tissue,the spring-loaded trocar cannula 10 will spring forward around theobturator 24, shielding the obturator point to prevent inadvertentcontact of the point with internal organs of the body inside the tissuebeing punctured.

FIG. 3 shows a safety trocar in which like reference numerals refer tothe elements previously described in FIG. 1. In FIG. 3 the obturator 24is enclosed in a bullet nosed obturator shield 32. The obturator shield32 is flanged at its proximal end to engage a spring 30 within theobturator handle 26. At its distal end the obturator shield has aslotted bullet-shaped nose 34. An end view of the bullet nose 34 isshown in FIG. 5a, with its slot 36. The slot 36 is seen to extendradially to the outer periphery of the bullet nose at the distal end ofthe obturator shield 32. In FIG. 3 the springs 18 and 30 are shown intheir uncompressed positions.

When pressure is initially exerted at the obturator handle 26, thespring 30 within the obturator handle compresses, as shown in FIG. 4.This compression of the spring 30 causes the obturator point 28 toextend beyond the bullet nose 34 of the shield through the slot 36, asshown in FIG. 5b. Further exertion of pressure at the handle 26 willcause the trocar cannula to compress the spring 18, and the obturatorpoint will then begin to extend out the distal end 12 of the trocarcannula 10. The extended obturator point will then puncture the tissueat the distal end of the trocar cannula until the point breaks throughthe inner surface of the tissue. At that time the resistance at thedistal end of the trocar will be removed, and the spring 18 will extendthe trocar cannula 10 forward about the point 28 of the obturator. Whenthe obturator and obturator handle are withdrawn from the trocarcannula, the bullet nosed shield will continue to protect the point ofthe obturator after it has been used. The spring-loaded trocar cannula10 provides protection against accidental puncture of an organ withinthe body, and the shield 32 continues to provide protection against userinjury after the obturator is withdrawn from the trocar cannula.

The bullet nosed end 34 of the shield 32 is shown in enlarged views inFIGS. 6-8. FIG. 6 shows an enlarged end view of the bullet nose 34 witha star-shaped slot 36. In the side view of FIG. 7, the slot 36 is seento extend toward the rear of the shield as indicated at 36a. Thesharpened edges of the star-shaped obturator point will thus extendradially through slots 36a to the outer perimeter of the shield, andwill hence cut a puncture the same diameter as the outer diameter of theshield 32. When the puncture is the same size as the shield, the shieldis enabled to readily spring forward to protect the point of theobturator as it breaks through the inner surface of the tissue. Thecross-sectional view of the bullet nose 34 in FIG. 8 shows the rearwardextension of the slot 36a in which the edges of the obturator pointslide, and the widened inner diameter 39 within the shield proximal thenose for the shaft of the obturator. The bullet nose 34 of the shieldaids penetration through the punctured tissue and improves the blendingbetween the obturator facets and the cannula, thereby improving theresponsiveness of the spring-loaded cannula.

Operation of the trocar with bullet nosed shield of FIGS. 3-8 is shownin FIGS. 9-11. FIG. 9 is a perspective view of the trocar with thetrocar cannula 10 compressed inside the trocar handle 16 so that thebullet nose 34 of the shield extends from the distal end 12 of thetrocar cannula. An end view of the distal end of the instrument is shownin FIG. 10. FIG. 11a is an enlarged side view of the distal end of theinstrument of FIG. 9, with the bullet nose 34 extended and thestar-shaped obturator point 28 still retracted within the shield. InFIG. 11b the obturator point 28 is shown extended from the slot 36 ofthe bullet nose 34.

FIGS. 12-12d are similar to FIGS. 6-8, and show the bullet nose 34 ofthe shield 32 when used with a triangular-pointed obturator. FIG. 12shows the bullet nose 34 in cross-section, with slot 36a extending alongthe side of the shield. FIG. 12a is a view of the distal end of thebullet nose, showing the triangular slot 36 extending to the peripheryof the shield. FIGS. 12b, 12c, and 12d are cross-sectional views takenas indicated for areas B, C, and D of FIG. 12.

Operation of the trocar with a triangular pointed obturator is as shownin FIGS. 13-15b. FIG. 13 is a perspective view of the trocar, with thetrocar cannula pressed into the handle 16 to reveal the bullet nose 34of the shield at the distal end 12 of the trocar cannula. The indicatoron the obturator handle is in the "on" position, indicating to the userthat the obturator point 28 is retracted within the bullet nosed shield32. FIG. 14 shows the distal end of the instrument and the trianglarpoint 28 of the obturator within the triangular slot 36. FIG. 15a showsthe bullet nose 34 of the shield 32 entending beyond the distal end 12of the trocar cannula 10, with the obturator point 28 still within thebullet nose 34. FIG. 15b shows the obturator point 28 in its extendedposition. It may be seen that the edge 29 of the obturator point 28 isfully extended to the outer periphery of the bullet nosed shield 32 soas to cut a puncture of the same diameter as that of the shield. Thethree semi-circular fingers of the rounded bullet nose 34 will then foldthe three opposing flaps of tissue aside as the shield 32 springsforward around the obturator point 28 when the puncture is made. Inaddition there is less trauma to the skin caused by pressing the roundedbullet nose fingers against the tissue as compared to the trauma causedby a tube-like shield.

An embodiment of an obturator and shield which requires only a shortextension of the obturator point is shown in FIGS. 27 and 28. In thisembodiment there are no slots 36a extending along the sides of theshield from the end slot 36. Instead, the obturator point 28 cuts onlyto a radial dimension 31 at the outer edges of the point, within theinner diameter 34' of the shield. In prior art instruments which cut tothis radius, the obturator point must be extended out of the shield tothe blend 37 of the point 28 and the round shaft 33 of the obturator. Inthe illustrated embodiment, the obturator point 28 need be extended onlyhalf this distance from the bullet nosed shield 34 in order to achieve acut of the full point diameter.

In the embodiment of FIGS. 27 and 28 the hemispheric bullet-shaped noseof the shield is seen to comprise three distal lobes, 134a, 134b, and134c, each with a semicircular distal end 135a, 135b, and 135c whichdefine the slot through which the obturator point 28 extends. Thetriangular pyramidal obturator tip 28 has three substantially flatsurfaces or faces 128a, 128b, and 128c which are ground to blend intothe cylindrical shaft 33 of the obturator as shown at 37. FIG. 28 showsthat each lobe 134a, 134b, and 134c is thickened to have a substantiallyflat inner surface 136a, 136b, 136c, one of which is shown in thisFIGURE. This inner surface contacts and fits against the proximalsurface of the corresponding face of the obturator tip when the tip isfully extended, at which time the proximal edge 137a, 137b, 137c of eachthickened lobe is substantially aligned with the blend 37 of each face.Thus, the geometry of the bullet-shaped nose is closely aligned withthat of the obturator tip, and the lobes will fit against the faces ofthe tip and follow the tip into the perforation as it is cut by the tip.The lobes will spread the edges of the perforation to accommodate thebullet-nosed shield and the shield will then spring forward to protectthe obturator tip as soon as the tip breaks through the tissue.

FIGS. 16 and 17 compare operation of the safety trocar of the presentinvention with that of prior instruments. Both FIGURES show trocars inoperation just as the obturator tip breaks through the tissue 50. FIG.17 illustrates operation of known instruments, in which the shield forthe obturator point is a tubular shield 44. This shield engages thetissue being punctured as shown at 45. This shield is not able toovercome the tissue resistance at 45 and spring forward to protect theobturator point until the obturator has made a puncture with a radius asindicated by R_(m). When this occurs, the obturator point 28 is alreadywell within the body and may have already damaged organs inside thebody. By comparison, the bullet nosed shield 34 contacts the tissueoutside the puncture site at points indicated at 35 in FIG. 16. Thesecontact points are at a much smaller radius R_(d) from the obturatorpoint 28. This smaller radius, together with the spherical shape of thenose 34, enable the bullet nosed shield to spring forward through thepuncture at a much earlier time than the prior tubular shield, therebyprotecting the point 28 of the obturator as soon as it breaks throughthe tissue.

By virtue of this superior protective action, a trocar can be made torely solely on the protective action of the spring-loaded shield 32without the spring-loaded trocar cannula. An embodiment of this type isshown in FIG. 18. The trocar cannula 70 is attached at its proximal endto the cannula handle 16. The obturator shield 32 and obturator 24 slidewithin the trocar cannula 70. A flange 66 at the proximal end of theshield 32 engages the spring 30, and is slideably engaged within apassageway 68 in the obturator handle 26. The bullet nose 34 of theshield is shown extended beyond the distal end 12 of the trocar cannula,but with the obturator point 28 still retracted within the shield. Asthe spring 30 is compressed when the bullet nose 34 contacts the tissuebeing punctured, the obturator point 28 will extend beyond the bulletnose and puncture the tissue. Once the point has broken through thetissue, the bullet nosed shield 32 will spring through the puncture toshield the point 28 within the body.

Prior to and after retraction of the obturator from the body, the bodyat the puncture site is generally insufflated with air. To prevent theair from escaping through the puncture, the trocar cannula and handleare generally equipped with a valve mechanism to prevent air leakage.FIG. 19 is a cross-sectional view of the trocar handle 16, showing aproximal tubular passageway 80 which is angled at its distal end. At thedistal end of the passageway 80 is a flap valve 74 which is hinged at75. A rubber-like sealing pad 78 is located on the side of the flapvalve which contacts the distal end of the passageway 80. At theproximal end of the passageway 80 is a replaceable gasket 72 which hasan aperture 73. The use of gaskets with different diameter aperturespermits the trocar to be used with instruments of many different sizes.The internal diameter of the passageway 80 is sized to allow the shield32 to smoothly slide through the passageway with the gasket 72 providinga seal around the shield. FIG. 21 shows an enlarged view of the trocarhandle 16, the obturator handle 26, the passageway 80, and the gasket72.

FIG. 20 shows the shield 32 and obturator 24 completely inserted withinthe trocar cannula 70. After the puncture is made, the shield 32 andobturator 24 are withdrawn from the trocar cannula 70, and the flapvalve 74 swings shut against the distal end of the passageway 80 as theshield 32 clears the distal end of the passageway. The flap valve swingsclosed under the force of a spring 76. The distal end of the passageway80 is thus securely sealed against air leakage while the shield is stillsealing the proximal end of the passageway 80 at the gasket 72. Theangled distal end of the passageway 80 permits the flap valve to beeasily pushed open by the shield, or any endoscope instrument andprevents the shield from becoming jammed between the sealing pad 78 andthe passageway as the flap valve closes. The distance between the flapvalve 74 and the proximal gasket 72 ensures that the valve will becompletely closed before the shield is removed from the gasket.Additionally the design of the trocar of FIG. 20 enables a user toselectively expose the obturator point or retract it into the shield.

During some surgical procedures, a substantial amount of force isrequired to cause the obturator to puncture the tissue. The suddenrelease of back pressure as the puncture is achieved often causes theobturator to burst through the tissue and injure organs within the body.FIG. 22 shows a trocar which prevents this sudden breakthrough andextension into the body. Located within the obturator handle 26 is amechanism 92 connected to the obturator or shield 32 which permits onlyincremental advancement of the obturator. In FIG. 22 this mechanism 92is illustrated as a pivoting toothed cam 94, which engages matchingteeth 96 on the shield 32. A return spring 98 is connected to theproximal end of the cam 94 so that the mechanism 92 will exhibit aratchet-like operation, permitting extension of the obturator in smallincremental distances. The mechanism 92 permits the obturator to beextended only a total distance "P" into the body, which is sufficient toprovide a puncture of the desired diameter. The ratchet mechanism 92 isonly illustrative of the types of mechanisms that may be employed. Othersuitable mechanisms include a linear or rotary double pawl clockescapement, or a coarse pitch screwing action whereby the obturator isincrementally advanced as the obturator handle is turned. Either theseor other suitable mechanisms will permit only incremental advancement ofthe obturator while providing tactile feedback to the surgeon indicatingthat the obturator is being advanced through the tissue.

FIGS. 23-26 illustrate a control on the trocar handle for enablingregulation of the insufflation of the body. The control includes apivotally mounted lever 100 located on the top of the trocar handle 16.The lever 100 is moveable to three discrete positions: off, insufflate,and desufflate. At a position just forward of the lever 100 is aninsufflation fitting 102, located over a passageway 108 which leads tothe interior of the handle 16. Connected to the pivot shaft 104 of thelever is a key 106, which pivots with the lever.

FIG. 25 is a plan view of the handle 16 with the top of the handleremoved. In this view the key 106 is seen to have two ears 112 and 114,each with an upward extending central dimple. As the key is rotated withthe lever, the dimples trace an arc along the top of the handle. Locatedin this arc of travel are the passageway 108 and two depressions 120 and122, which act as detent positions for the dimples on the key ears 112and 114. Located on the proximal extension of the key 106 is a pointer110, which opposes an upward extension 75 of the flap valve 74 withinthe handle 16 (see FIG. 24). FIG. 24 illustrates that the angled distalend of the passageway 80 may have its own circular gasket 78' locatedaround the distal end of the passageway.

When the lever 100 is rotated to the "off" position, the dimple on thekey ear 112 clicks into the depression 120 and the dimple on the key ear114 fits into the inner end of the insufflation passageway 108, therebysealing the passageway. With the passageway 108 sealed, pressurized airinside the trocar cannula 70, the trocar handle 16 and the body will notleak out of the insufflation fitting. The flap valve 74 seals the distalend of the passageway 80 at this time.

When it is desired to insufflate the body, a source of pressurized gasis connected to the insufflation fitting 102 and the lever is moved tothe "insufflate" position as shown in FIGS. 23, 24, and 25. In thisposition the passageway 108 is not blocked by the key 106 andpressurized gas may enter the interior of the handle and the trocarcannula through the insufflation fitting 102, insufflating the body.After the body has been properly insufflated with gas, the lever 100 maybe moved back to the "off" position to seal the pressurized gas in thetrocar, and the gas source may be removed from the fitting 102. When itis desired to desufflate the body, the lever 100 is pivoted to the"desufflate" position as shown in FIG. 26. The pivoting of the levercauses the key pointer 110 to contact the flap valve extension 75 andswing the flap valve away from its sealing position at the distal end ofthe passageway 80. Pressurized gas within the handle and trocar cannulawill thus be vented through the passageway 80. As the key swings to itsdetent position the dimple on the key ear 114 clicks into the depression122 and the dimple on the key ear 112 seals the passageway 108 toprevent the venting of air through the passageway 108 and theinsufflation fitting 102.

What is claimed is:
 1. A trocar including:(i) trocar tube having a proximal end and a distal end into which may be placed an obturator inserted into a safety shield, (ii) an obturator having a cylindrical shaft attached to a perforating tip and extendable through said tube to perforate tissue at the distal end of the tube, said perforating tip having three cutting edges separated by three substantially flat surfaces, each of said substantially flat surfaces forming a face comprising a pair of diverging sides, each of said diverging sides intersecting at a cutting edge, and each of said flat surfaces intersecting along said cylindrical shaft in a smooth transition, and (iii) a safety shield placed around said obturator and extendable to shield the tip of said obturator, both of said safety shield and said obturator emplaceable in said trocar tube, said shield exhibiting a rounded distal end with a slot for passage of said obturator tip therethrough, said slot bounded by three distally extending lobes formed on the distal end of said shield, the proximal end of said lobes opposing one another alongside each of the cutting edges of said perforating tip when said tip is extended through said slot, said slot generally conforming to the geometry of said perforating tip.
 2. The trocar of claim 1 wherein said rounded distal end is hemispheric in profile.
 3. The trocar of claim 1 wherein said slot extends radially to the outermost radial cutting edge of said obturator tip.
 4. The trocar of claim 1 wherein each of said lobes has an inner surface which contacts a face of said perforating tip when said tip is extended through said slot.
 5. The trocar of claim 1 further including resilient means located at the end of said safety shield enabling said safety shield to retract proximally to allow said perforating tip to be exposed at the distal end of said safety shield when force is exerted against the distal end of said safety shield.
 6. The trocar of claim 5 further including a housing located at the proximal end of said safety shield, said housing including an abutment surface, and said safety shield including a proximal flange, wherein said resilient means is mounted for compression between said flange and said abutment surface. 